FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
169729–169752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1979
FILTER SYSTEM, ALTNER DISPOSABLE
K790209 · GAZ
Orthopedic Equipment Co., Inc.
General Hospital · 27d
Cleared Feb 26, 1979
LENS, POLYCORE
K790215 · HQG
Polycore Optical Pte , Ltd.
Ophthalmic · 27d
Cleared Feb 26, 1979
VAGINALIS, HAEMOPHILUS
K790229 · JSH
Los Angeles Biological Products
Microbiology · 24d
Cleared Feb 26, 1979
TOURNIQUET TEST GAGE
K790247
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 20d
Cleared Feb 26, 1979
FUL-VUE ASPHERIC CATARACT LENS
K790251 · HQG
American Optical Corp.
Ophthalmic · 20d
Cleared Feb 26, 1979
CEPTOR HESIVE
K790269 · GXY
Med General
Neurology · 21d
Cleared Feb 26, 1979
MINILITH AND MICROLITH
K790276 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 18d
Cleared Feb 26, 1979
MONITOR, ELECTROCARDIOSCOPE
K790292 · DRT
Burdick Corp.
Cardiovascular · 17d
Cleared Feb 26, 1979
HEARING AID, OTICON I II H
K790301 · ESD
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Feb 26, 1979
DRUSHOE
K790326 · KNP
J.E. Hanger & Co. , Ltd.
Physical Medicine · 11d
Cleared Feb 26, 1979
ANGIO-FLO
K790327 · KRA
Deseret Medical, Inc.
Cardiovascular · 10d
Cleared Feb 23, 1979
QUINTON STATUS 1000
K782072 · DQK
Quinton, Inc.
Cardiovascular · 72d
Cleared Feb 23, 1979
DINAMAP MODELS 1160 AND 1165
K782073 · DSK
Applied Medical Research
Cardiovascular · 72d
Cleared Feb 23, 1979
TELEMETRY SYSTEM 315
K790144 · DRG
Ge Medical Systems Information...
Cardiovascular · 35d
Cleared Feb 23, 1979
INTRA-AORTIC BALLOON-PUMP
K790241 · DSP
Avco Medical Products
Cardiovascular · 22d
Cleared Feb 23, 1979
MOVABLE CORE SAFETY GUIDE
K790258 · DQX
Cordis Corp.
Cardiovascular · 17d
Cleared Feb 22, 1979
RIA KIT, GLUCOSE
K782143 · JME
Serono Laboratories, Inc.
Chemistry · 57d
Cleared Feb 22, 1979
ARTIFICIAL KIDNEY, C-DAK 0.6D
K782151 · FJI
Cordis Corp.
Gastroenterology & Urology · 58d
Cleared Feb 22, 1979
3-WAY STOPCOCK
K782168 · FMG
Medex, Inc.
General Hospital · 55d
Cleared Feb 22, 1979
ACCESSORY KIT, CENTRIFICHEM
K790041 · JQW
Union Carbide Corp.
Chemistry · 45d
Cleared Feb 22, 1979
REAGENT KIT, BAKERS DIAGNOSTIC
K790044 · CGX
J.T. Baker Chemical Co.
Chemistry · 48d
Cleared Feb 22, 1979
REAGENT KIT, CHLORIDE/CARBON DIOXIDE
K790045 · JFS
J.T. Baker Chemical Co.
Chemistry · 48d
Cleared Feb 22, 1979
TUBING, DYNACOR UNIVERSAL
K790055 · GCX
Medline Industries, Inc.
General Hospital · 44d
Cleared Feb 22, 1979
ANALYZER, IMPACT 200
K790072 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 42d